Sharpening the Focus on FDA Supplier Controls for Medical Implant-Grade Cobalt Chrome


CAROL STREAM, ILLINOIS -- Firth Rixson Metals, a global leader in specialty metals manufacturing and distribution based in the United Kingdom, and Banner Medical, a leading provider of supply chain solutions for medical-grade materials to the device, implant, and instrument industry, announce their exclusivity agreement for sales and marketing for Cobalt Chrome in the United States, effective January 1st,2014.



"The medical-grade metal materials that Firth Rixson Metals produces are of the highest standards. By combining this offering with Banner Medical's expertise in quality assurance, we will meet the stringent demands of the medical industry," stated Elinor Oldroyd, GM of Firth Rixson Metals.



"Banner Medical specializes in medical-grade materials and offers deep expertise in the quality management that is necessary to fully comply with FDA 21 CFR 820. The depth, breadth and detail of Banner's approach to quality management and supply chain management is unique and that distinction justifies the patent-pending status of Banner's Essential Quality Systems," says Banner Medical Executive Vice President / Chief Operating Officer Dan Stoettner. "Firth Rixson shares our commitment to vigilance and quality in both products and service."



The Firth Rixson-Banner Medical agreement focuses on the Device industry's need for precision-ground cobalt chrome materials. Stoettner went on to say, "Given the importance of cobalt chrome to today's device, implant and instrument industry, we strongly believe that the Firth Rixson-Banner Medical alliance can help our customers realize true supply chain control on Cobalt Chrome materials, making them able to effectively address the unprecedented FDA scrutiny which exists today in the United States."



Firth Rixson's technological and operational excellence, combined with the firm's economies of scale, has made the company the metals provider of choice for demanding customers in diverse specialized industries in more than 40 countries. www.firthrixson.com.



Banner Medical serves the medical device, implant, and instrument industry with medical-grade metal materials; Banner Medical is ISO 13485 and ISO 9001 certified, and FDA CFR part 820 compliant. 



BILL NORLANDER

Medical Products Specialist

BANNER MEDICAL

494 East Lies Road

Carol Stream, IL 60188-9425

P: 630-868-1230

F: 630-653-7555

E: bnorlander@banner-medical.com



MIKE HADLEY

Supply Chain Manager

BANNER MEDICAL

494 East Lies Road

Carol Stream, IL 60188-9425

P: 630-868-1229

F: 630-653-7555

E: mhadley@banner-medical.com


All Topics